Study to Assess the Efficacy of Ipratropium Bromide Associated With High Dose Salbutamol by Repeated Nebulisation Versus Repeat Nebulisation of Salbutamol Alone, in Acute Asthmatic Attacks in Young Children
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Keep this study
Lead
Boehringer Ingelheim
Age
3–6
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Boys or girls between 3 and 6 years old
Presenting to emergency departments with an acute asthmatic attack
Requiring nebulised bronchodilator therapy
Rint increased by 200 % compared to theoretical Rint
Signed, informed consent obtained from the child's parents/legal guardian in accordance with current national legislation and good clinical practice (GCP) defined by the International Conference on Harmonization (ICH)
You may not be if
Ipratropium bromide received within four hours before admission
First acute asthmatic attack
Hospital admission to intensive care with asthma within six months before inclusion
Hospital admission for asthma during the month prior to inclusion
Corticosteroid-dependent asthma (oral corticosteroid therapy) or recently stopped corticosteroid therapy
Concomitant cardiac disease
Life threatening disease requiring immediate management; including: silent chest on auscultation, cyanosis, bradycardia less than 60 beats/min (bpm), confusion, coma
Hypersensitivity to ipratropium bromide, salbutamol, or to any of their excipients
Renal or hepatic insufficiency
Poorly controlled diabetes
Patients suffering from a disease considered to be severe by the investigator and which, in the opinion of the investigator, could interfere or invalidate the measurements performed in the trial
Past history of lung surgery
Major respiratory disease: pulmonary fibrosis, bronchiectasis, sarcoidosis, tuberculosis, respiratory disease due to AIDS, cystic fibrosis
Patients unable to follow with protocol or correctly undergo the evaluations
Patients who are taking part in another clinical trial during this trial or who have done so within the month before the trial
Previous participation in this trial
Clareo Health | Study to Assess the Efficacy of Ipratropium Bromide Associated With High Dose Salbutamol by Repeated Nebulisation Versus Repeat Nebulisation of Salbutamol Alone, in Acute Asthmatic Attacks in Young Children
